Article R5121-20
Each chemical, pharmaceutical, biological and non-clinical trial gives rise to a report drawn up by the investigator who carried out the trial. This report, dated and signed, states in particular: 1°…
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Showing 841–850 of 3833 articles for “Art. n° 20-16.802”
Each chemical, pharmaceutical, biological and non-clinical trial gives rise to a report drawn up by the investigator who carried out the trial. This report, dated and signed, states in particular: 1°…
To be eligible for election as a member of the Disciplinary Board, a pharmacist must on the closing date for the submission of candidacies:1° Be a voter under the Order of Pharmacists of New Caledonia…
In the event of an election of all the members of the Disciplinary Board, in order to allow for subsequent renewal by half, lots are drawn as soon as the results are known to determine those members w…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by reasoned decision, refuse to include a medicinal product on the list referred to in Article R. 5…
The detailed rules for the application of sections 1 to 12 of this chapter are determined as necessary, after obtaining the opinion of the Director General of the Agence nationale de sécurité du médic…
For the purposes of this section, advanced therapy medicinal products prepared on an ad hoc basis mean the advanced therapy medicinal products mentioned in 17° of Article L. 5121-1.For the purposes of…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or remove the registration of a medicinal product from the list provided for in article R. 5…
Blood establishments and organisations or companies manufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma i…
Without prejudice to the provisions of Chapter III of Title III of Book V of the Environment Code, the provisions of Articles R. 1243-34 to R. 1243-38 are applicable to the conditions for authorisatio…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall draw up the list of medicinal products, known as medicinal products for officinal use, which the d…
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